CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 186 enrolled
Drug / intervention
Salmeterol 50 mcg BID +2 moredrug
Likely dose
Salmeterol 50 mcg BIDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00355342
NCT00355342Phase 4Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel-Group Clinical Trial Evaluating the Effect of the Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Twice Daily Via DISKUS® Inhaler Versus Salmeterol 50mcg Twice Daily Via DISKUS® Inhaler on Bone Mineral Density in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline·interventional·Posted Jul 21, 2006·Updated Jul 2, 2018

In Brief

A Phase 4 clinical trial evaluating Salmeterol 50 mcg BID, Fluticasone Propionate/Salmeterol 250/50 mcg BID, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 186 participants across 37 sites.

Detailed Summary

This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (COPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2006
Enrollment StartApr 28, 2004
Primary CompletionSep 6, 2007
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 19.9 years ago

Interventions

Salmeterol 50 mcg BIDdrug

Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.

Fluticasone Propionate/Salmeterol 250/50 mcg BIDdrug

Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.

DISKUS inhalerdevice

Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.